Gabriel WAUER,Frank SEIBERTZ,Shu-Lun WEINHEIMER,Thomas HILLE
申请号:
MX2015016123
公开号:
MX362614B
申请日:
2014.06.04
申请国别(地区):
MX
年份:
2019
代理人:
摘要:
The invention relates to transdermal therapeutic system for the transdermal administration of buprenorphine, comprising a buprenorphine-containing self-adhesive layer structure comprising A) a buprenorphine-impermeable backing layer, and B) a buprenorphine-containing pressure-sensitive adhesive layer on said buprenorphine-impermeable backing layer, the adhesive layer comprising a) at least one polymer-based pressure-sensitive adhesive, b) an analgesically effective amount of buprenorphine base or a pharmaceutically acceptable salt thereof, c) a viscosity-increasing substance in an amount of about 0.1% to about 8% of said buprenorphine-containing pressure-sensitive adhesive layer, and d) a carboxylic acid selected from the group consisting of oleic acid, linoleic acid, linolenic acid, levulinic acid and mixtures thereof, in an amount sufficient so that said analgesically effective amount of buprenorphine is solubilized therein to form a mixture including said viscositiy-increasing substance, and wherein the carboxylic acid-, buprenorphine- and viscosity-increasing substance-containing mixture forms dispersed deposits in the said pressure-sensitive adhesive, and wherein said buprenorphine-containing pressure-sensitive adhesive layer is the skin contact layer.La invención se relaciona con sistema terapéutico transdérmico para la administración transdérmica de buprenorfina, comprendiendo una estructura de capa auto-adhesiva conteniendo buprenorfina comprendiendo A) una capa de respaldo impermeable a la buprenorfina, y B) una capa adhesiva sensible a la presión conteniendo buprenorfina sobre dicha capa de respaldo impermeable a la buprenorfina, la capa adhesiva comprendiendo a) al menos un adhesivo sensible a la presión de base polimérica, b) una cantidad efectiva analgésicamente de base de buprenorfina o una sal farmacéuticamente aceptable de la misma, c) una sustancia que aumenta la viscosidad en una cantidad de alrededor de 0,1% a alrededor de 8% de dicha capa adhesiv